A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV

Vigonvita Life Sciences

Status and phase: Completed; Phase 2

Conditions: Respiratory Syncytial Virus Infection

Treatments: Drug: Deuremidevir Hydrobromide for Suspension; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06206720

VV116-RSV-II/III-01

Details and patient eligibility

About

To evaluate the safety, efficacy, pharmacokinetic (PK) characteristics and antiviral activity of different doses of Deuterium Hydrobromide for suspension in the treatment of respiratory syncytial virus infection in infants.

Full description

This trial is a randomized, double-blind, placebo-controlled, dose-ascending trial, and the subjects are infants infected with RSV from 1 to 24 months.

It is estimated that 60 subjects will be included and divided into low-dose group (15 mg/kg，BID), middle-dose group (20 mg/kg,BID) and high-dose group (20 mg/kg,TID), with 20 cases in each group, and they will be randomly assigned to the experimental drug group and the placebo group according to the ratio of 3: 1.

Enrollment: 60 patients

Sex: All

Ages: 1 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female infants ≥1 month and ≤24 months；
2. Diagnosis of RSV infection by antigen detection or nucleic acid within 36 hours preceding initial dosing；
3. Onset of RSV infection symptoms should be ≤ 5 days；
4. Patient must weigh ≥ 2.5 kg and ≤ 20 kg at screening；
5. Patient must have a Wang Respiratory Score ≥ 5;
6. Patient who are hospitalized or in emergency/outpatient department and are expected to be hospitalized;
7. The parent/legal guardian must have provided written informed consent for the patient to participate.

Exclusion criteria

1. Patients who are less than 12 months old and whose head circumference is not within the normal range corresponding to their age and gender at the time of screening;
2. Patients who have received prohibited used drugs (except external preparations) specified in the protocol for a specified time.
3. Requires vasopressors or inotropic support at the time of enrollment;
4. Patients with known SARS-CoV-2 infection, influenza virus infection, mycoplasma infection or bacterial infection；
5. Patients with hypercapnia (Except for patients who have recovered at the time of screening);
6. Chronic or persistent feeding difficulties;
7. Concurrent gastrointestinal conditions that could seriously, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product;
8. Symptomatic because of inborn errors of metabolism;
9. Bronchopulmonary dysplasia requiring assisted ventilationor with clinically significant congenital respiratory abnormalities, except for the result of RSV infection;
10. Patients with congenital heart disease (CHD) with significant hemodynamic changes, except simple CHD (such as patent ductus arteriosus, atrial septal defect or ventricular septal defect without hemodynamic influence).
11. Clinical evidence of hepatic decompensation
12. Renal failure including renal anomalies likely to be associated with renal insufficiency;
13. Patient is known to be HIV-positive (or the mother, if the potential patient is a child aged <6 months);
14. Suspected or known to have congenital acquired immunodeficiency;
15. A history of epilepsy or seizures;
16. A history of high allergies;
17. Any active or uncontrolled respiratory, cardiac, hepatic, central nervous system, or renal disease unrelated to RSV infection at baseline or any other medical condition that in the opinion of the investigator renders the patient unsuitable for enrollment;
18. Participation in an investigational drug or device study within 30 days prior to the date of screening;
19. Failure to satisfy the investigator of fitness to participate for any other reason.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Deuremidevir Hydrobromide for Suspension

Experimental group

Description:

Deuremidevir Hydrobromide for Suspension will be orally administered at the dosing levels of 15 mg/kg BID, 20 mg/kg BID, or 20 mg/kg TID for five days according to the weight of patients.

Treatment:

Drug: Deuremidevir Hydrobromide for Suspension

Placebo

Experimental group

Description:

Placebo will be orally administered at the dosing levels of 15 mg/kg BID, 20 mg/kg BID, or 20 mg/kg TID for five days according to the weight of patients.

Treatment:

Drug: Placebo